Efficacy and Safety of Baclofen for Maintenance of Abstinence in Alcohol Dependent Patients

Last updated: July 29, 2014
Sponsor: Ethypharm
Overall Status: Completed

Phase

3

Condition

Alcohol Dependence

Substance Abuse

Addictions

Treatment

N/A

Clinical Study ID

NCT01738282
ALP 2011007/002
  • Ages > 18
  • All Genders

Study Summary

The purpose of the study is to assess the efficacy of Xylka® (baclofen) compared to placebo on continuous abstinence rate during 20 weeks of treatment, after withdrawal, in alcohol dependent patients receiving Brenda therapy sessions.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult patients meeting DSM IV(Diagnosis and Statistical Manual of Mental Disorders, 4th edition) criteria for alcohol dependence

  • Willing to participate in the study and express a desire to achieve the objective ofcontinuous and long term abstinence after withdrawal

  • Abstinent (last drinking) for a minimum of 3 days and maximum of 14 days

  • At least one previous abstinence attempt

Exclusion

Exclusion Criteria:

  • Need for a stay at the end of the withdrawal period in a health care andrehabilitation institution specialized in addiction

  • Need for a heavy psychosocial out of hospital care

  • History of baclofen intake, by prescription or self medication

  • Porphyria

  • Concomitant treatment with one or several drugs for the maintenance of abstinence

  • Severe renal, cardiac or pulmonary disorder

  • Epilepsy or history of epilepsy

  • Concomitant treatment with psychotropic drugs, except antidepressants at stable dosefor 2 months, diazepam and oxazepam

  • Severe psychiatric disease (schizophrenia and bipolar disorder)

  • Suicidal risk or history of suicide

  • Clinically significant cognitive disorders

  • Hepatic encephalopathy

  • Ongoing dependence or within the last 12 months on other addictive substances (opioid,cocaine, cannabis, other substances or drugs…), excepted tobacco

Study Design

Total Participants: 316
Study Start date:
December 01, 2012
Estimated Completion Date:
July 31, 2014

Connect with a study center

  • empty

    Agen,
    France

    Site Not Available

  • CHU Nord

    Amiens,
    France

    Site Not Available

  • Angers,
    France

    Site Not Available

  • Clinique Montberon

    Aucamville,
    France

    Site Not Available

  • Centre hospitalier de l'Yonne

    Auxerre,
    France

    Site Not Available

  • Bron,
    France

    Site Not Available

  • CHU

    Clermont Ferrand,
    France

    Site Not Available

  • Clermont de l'Oise,
    France

    Site Not Available

  • Hopital Beaujon

    Clichy,
    France

    Site Not Available

  • Dax,
    France

    Site Not Available

  • Centre hospitalier

    Dijon,
    France

    Site Not Available

  • Centre hospitalier

    Erstein,
    France

    Site Not Available

  • Hopital Corentin Celton

    Issy les Moulineaux,
    France

    Site Not Available

  • L'Arbresle,
    France

    Site Not Available

  • Centre hospitalier

    La Membrolle sur Choisille,
    France

    Site Not Available

  • Hopital Michallon

    La Tronche,
    France

    Site Not Available

  • Centre hospitalier

    Le Mans,
    France

    Site Not Available

  • Centre hospitalier Emile Roux

    Le Puy en Velay,
    France

    Site Not Available

  • CHRU

    Lille,
    France

    Site Not Available

  • CSAPA

    Lille,
    France

    Site Not Available

  • Limoges,
    France

    Site Not Available

  • Hopital de la Croix Rousse

    Lyon,
    France

    Site Not Available

  • Hopital Sainte Marguerite

    Marseille,
    France

    Site Not Available

  • Centre hospitalier

    Montauban,
    France

    Site Not Available

  • Morlaix,
    France

    Site Not Available

  • Hopital Villemin

    Nancy,
    France

    Site Not Available

  • CHU

    Nantes,
    France

    Site Not Available

  • Centre hospitalier

    Nice,
    France

    Site Not Available

  • CHRU

    Nimes,
    France

    Site Not Available

  • Hopital Bichat Claude Bernard

    Paris,
    France

    Site Not Available

  • Hopital Cochin

    Paris,
    France

    Site Not Available

  • Hopital Fernand Widal

    Paris,
    France

    Site Not Available

  • Hopital Saint Anne

    Paris,
    France

    Site Not Available

  • Centre hospitalier

    Perpignan,
    France

    Site Not Available

  • Centre hospitalier

    Pont du Casse,
    France

    Site Not Available

  • empty

    Pontorson,
    France

    Site Not Available

  • Reims,
    France

    Site Not Available

  • Hopital Pontchaillou

    Rennes,
    France

    Site Not Available

  • Hopital de la Fraternité

    Roubaix,
    France

    Site Not Available

  • CHU

    Rouen,
    France

    Site Not Available

  • Saint Egreve,
    France

    Site Not Available

  • Centre hospitalier

    Saint Omer,
    France

    Site Not Available

  • Hopital René Muret

    Sevran,
    France

    Site Not Available

  • CSAPA

    Seynod,
    France

    Site Not Available

  • Centre hospitalier intercommunal

    Toulon,
    France

    Site Not Available

  • Hopital Brabois

    Vandoeuvre les Nancy,
    France

    Site Not Available

  • Hopital Paul Brousse

    Villejuif,
    France

    Site Not Available

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